Effectiveness of Nutritional and Exercise Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Putra Malaysia
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Mean Changes in Risk of Falls
Study Overview
Brief Summary
Falls is a major concern in geriatrics due to its high prevalence and various adverse health complications among elderly population. Risk of falls can be reduced by improving nutritional status and increase the level of physical activity. Besides, knowledge regarding risk of falls, nutrition and exercise are important in reducing the risks of falls. Therefore, this study aims to develop, implement and evaluate the effectiveness of a nutritional education and exercise intervention among community dwelling older adults in Selangor.
Detailed Description
General Objective: To develop, implement and evaluate the effectiveness of nutrition education and exercise intervention on risk of fall among older person in Selangor.
Specific Objectives:
- To determine the risk of falls among the older adults.
- To determine the dietary intake, anthropometric parameters (body mass index, mid upper arm circumference, calf circumference, body fat percentage and skeletal muscle mass), nutritional status, level of physical activity, functional status, perceived quality of life, risk of sarcopenia, level of knowledge, attitude and practice (KAP) towards falls' risk reduction, nutrition and exercise among the older adults.
- To identify the factors determining risk of falls among older adults.
- To evaluate the implementation process of the nutrition education and exercise intervention program (attendance and feedback of the program).
- To determine the mean differences in risk of falls, dietary intake, anthropometric parameters, nutritional status, physical activity, functional status, perceived quality of life, risk of sarcopenia and knowledge, attitude and practice (KAP) towards falls' risks reduction, nutrition and exercise between intervention and control groups before and after intervention.
The proposed study location is in Selangor. This is a randomized wait-list controlled trial for 3 months (12 weeks) among community dwelling older adults in Selangor. A two-stage sampling design will be applied. Firstly, a random sampling will be applied to select two districts from Selangor. This is followed by a purposive sampling to recruit eligible subjects according to inclusion criteria.
Subjects will be recruited from free living older adults residing in Selangor through various community settings including including affiliations of National Council of Senior Citizens Organisations Malaysia (NACSCOM), University of Third Age (U3A) and Alzheimer's Disease Foundation Malaysia (ADFM).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men or women aged 60 years old to 80 years old in Malaysia
- •Able to ambulate without personal assistance
- •Able to read and write
Exclusion Criteria
- •Self-reported chronic diseases (severely poorly control diabetics and hyperlipidemia, heart-related disease, Chronic obstructive pulmonary disease, osteoarthritis, osteoporosis, stroke, cancer, asthma, renal dysfunction, terminally ill that may limit participations in physical activity)
- •Any sustained fracture or undergoing surgery (hip, vertebrata) in past six months
- •Bedridden
- •Sensory impairment (visual & hearing) that will interfere with communication
- •Anyone who participated in similar program before
Outcomes
Primary Outcomes
Mean Changes in Risk of Falls
Time Frame: Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12)
Risk of falls of the respondents will be determined using Timed Up and Go (TUG) test, Five Times Sit to Stand Test (5XSST) and 30 Second Sit to Stand Test (30CST). For the Timed Up and Go (TUG) test, respondents will be timed while they rise from an arm- chair, walk at a comfortable and safe pace to a line on the floor three meters away (10 feet), turn and walk back to the chair and sit down again. The respondents will walk through the test once before being timed to become familiar with the test.
Secondary Outcomes
- Mean Changes in Skeletal Muscle Mass(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Weight(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Gait Speed(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Height(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in calf-circumference(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Vitamin D Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Nutritional Status(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Functional Status(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Handgrip Strength(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Protein Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Calcium Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Sleep Quality(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Energy Intake(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Physical Activity Level(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
- Mean Changes in Knowledge, Attitude and Practice on Falls' risk reduction, nutrition and exercise Questionnaire(Assessments will be performed at Baseline (Week 0) and Post-Intervention (Week 12))
- Mean Changes in Quality of Life(Assessments will be performed at Baseline (Week 0), mid-intervention (Week 6) and Post-Intervention (Week 12))
Investigators
Chan Yoke Mun
Professor
Universiti Putra Malaysia